Heart FailureEcho-CRTNCT02986633
Echocardiography in Cardiac Resynchronization Therapy (Echo-CRT)
An observational study of Heart Failure and Cardiac Resynchronization Therapy, run by Lille Catholic University at 1 site in France.
Trial summary
The present observational prospective study aims at identifying echocardiographic parameters (based on the Left Bundle Branch Block (LBBB)-like contraction of the left ventricle (LV) ascertained using new methods of echocardiography including speckle tracking strain) that are linked to Cardiac Resynchronization… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiac Resynchronization Therapy
- What is being tested?
- Echocardiography
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Dec 2025
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with LV systolic dysfunction and QRS duration > 120 ms receiving CRT at GHICL.
Who may be able to join
- Heart failure with left ventricular ejection fraction less than 35 %
- QRS duration over than 120 ms
- Clinical indication for CRT
Who cannot join
- Rythmologic indication of CRT for atrial fibrillation control
- Rythmologic indication of CRT for left ventricular ejection fraction between 35% and 45%
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospitals of Lille Catholic University (GHICL)
Lomme, 59462
Amélie Lansiaux, MD, PhD, 00 33 3 20 52 69, lansiaux.amelie@ghicl.net
About this study
Official title: Prediction of Response to Cardiac Resynchronization Therapy by New Echocardiographic Methods
The present observational prospective study aims at identifying echocardiographic parameters (based on the Left Bundle Branch Block (LBBB)-like contraction of the left ventricle (LV) ascertained using new methods of echocardiography including speckle tracking strain) that are linked to Cardiac Resynchronization Therapy (CRT) response and a better outcome following CRT
Read the detailed description
The Cardiac Resynchronization Therapy (CRT) reduces mortality of patients with heart failure and reduced LV ejection fraction. The clinical benefit of CRT is mediated by LV reverse remodelling (decrease in LV end-systolic volume over time). However, 30 to 50 % of these patients will not experience LV reverse remodelling following CRT.
Classical parameters of dyssynchrony obtained by conventional methods of echocardiography (including doppler tissue imaging) have a limited value in predicting CRT response. Meanwhile, patients with a Left Bundle Branch Block (LBBB) on the electrocardiogram experience more frequently LV reverse remodelling than those without a LBBB.
LBBB is responsible for specific LV contractile abnormalities that can be identified by speckle tracking strain echocardiography (early septal contraction, stretching of late contraction of the postero-lateral wall). The predictive value of these abnormalities remains to be studied.
Thus, it has been hypothesised that these LBBB-related contractile abnormalities may be independent predictors of LV reverse remodelling and outcome following CRT.
The present observational prospective study aims at identifying echocardiographic parameters (based on the LBBB-like contraction of the LV ascertained using new methods of echocardiography including speckle tracking strain) that are linked to CRT response and a better outcome following CRT.
- Conditions
- Heart Failure, Cardiac Resynchronization Therapy
- Being tested
- Echocardiography
- Keywords
- Cardiac Resynchronization Therapy, Echocardiography, Biventricular Pacing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with heart failure and CRT | Heart failure with left ventricular ejection fraction less than 35 % treated with CRT Receives: Other: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in left ventricular end-systolic volume measured by echocardiography
Measured: 9 months after implantation
Secondary outcomes (5)
Death rate
Measured: 2, 4, 6, 8 and 10 years after implantation
re-hospitalisation rate
Measured: 2, 4, 6, 8 and 10 years after implantation
Changes in left ventricular ejection fraction measured by echocardiography
Measured: 9 months after implantation
Changes in left ventricular end-diastolic volume measured by echocardiography
Measured: 9 months after implantation
Changes in left ventricular longitudinal strain measured by echocardiography
Measured: 9 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startDec 2014
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvestre Maréchaux, MD, PhD, Principal investigator, Hospital of Lille Catholic University (GHICL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986633
- Sponsor's protocol ID
- OBS-009
- Acronym
- Echo-CRT
- Status last verified
- Jul 2018
- First submitted
- 5 Dec 2016
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Layec J, Decroocq M, Delelis F, Appert L, Guyomar Y, Riolet C, Dumortier H, Mailliet A, Tribouilloy C, Marechaux S, Menet A. Dyssynchrony and Response to Cardiac Resynchronization Therapy in Heart Failure Patients With Unfavorable Electrical Characteristics. JACC Cardiovasc Imaging. 2023 Jul;16(7):873-884. doi: 10.1016/j.jcmg.2022.12.023. Epub 2023 Mar 8.
PubMed 37038875Appert L, Menet A, Altes A, Ennezat PV, Bardet-Bouchery H, Binda C, Guyomar Y, Delelis F, Castel AL, Le Goffic C, Guerbaai RA, Graux P, Tribouilloy C, Marechaux S. Clinical Significance of Electromechanical Dyssynchrony and QRS Narrowing in Patients With Heart Failure Receiving Cardiac Resynchronization Therapy. Can J Cardiol. 2019 Jan;35(1):27-34. doi: 10.1016/j.cjca.2018.10.019. Epub 2018 Nov 14.
PubMed 30595180
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Response to Cardiac Resynchronization Therapy by New Echocardiographic Methods
- ClinicalTrials.gov ID
- NCT02986633
- Acronym / sponsor ID
- Echo-CRT / OBS-009
- Conditions
- Heart Failure, Cardiac Resynchronization Therapy
- Keywords
- Cardiac Resynchronization Therapy, Echocardiography, Biventricular Pacing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present observational prospective study aims at identifying echocardiographic parameters (based on the Left Bundle Branch Block (LBBB)-like contraction of the left ventricle (LV) ascertained using new methods of echocardiography including speckle tracking strain) that are linked to Cardiac Resynchronization Therapy (CRT) response and a better outcome following CRT
Detailed description
The Cardiac Resynchronization Therapy (CRT) reduces mortality of patients with heart failure and reduced LV ejection fraction. The clinical benefit of CRT is mediated by LV reverse remodelling (decrease in LV end-systolic volume over time). However, 30 to 50 % of these patients will not experience LV reverse remodelling following CRT.
Classical parameters of dyssynchrony obtained by conventional methods of echocardiography (including doppler tissue imaging) have a limited value in predicting CRT response. Meanwhile, patients with a Left Bundle Branch Block (LBBB) on the electrocardiogram experience more frequently LV reverse remodelling than those without a LBBB.
LBBB is responsible for specific LV contractile abnormalities that can be identified by speckle tracking strain echocardiography (early septal contraction, stretching of late contraction of the postero-lateral wall). The predictive value of these abnormalities remains to be studied.
Thus, it has been hypothesised that these LBBB-related contractile abnormalities may be independent predictors of LV reverse remodelling and outcome following CRT.
The present observational prospective study aims at identifying echocardiographic parameters (based on the LBBB-like contraction of the LV ascertained using new methods of echocardiography including speckle tracking strain) that are linked to CRT response and a better outcome following CRT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with heart failure and CRT | – | Other: EchocardiographyHeart failure with left ventricular ejection fraction less than 35 % treated with CRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with LV systolic dysfunction and QRS duration > 120 ms receiving CRT at GHICL.
Key inclusion criteria (3 listed)
- Heart failure with left ventricular ejection fraction less than 35 %
- QRS duration over than 120 ms
- Clinical indication for CRT
Key exclusion criteria (2 listed)
- Rythmologic indication of CRT for atrial fibrillation control
- Rythmologic indication of CRT for left ventricular ejection fraction between 35% and 45%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography | Other | Patients with heart failure and CRT |
Primary outcome
Changes in left ventricular end-systolic volume measured by echocardiography
Time frame: 9 months after implantation
5 secondary outcomes
Death rate
Time frame: 2, 4, 6, 8 and 10 years after implantation
re-hospitalisation rate
Time frame: 2, 4, 6, 8 and 10 years after implantation
Changes in left ventricular ejection fraction measured by echocardiography
Time frame: 9 months after implantation
Changes in left ventricular end-diastolic volume measured by echocardiography
Time frame: 9 months after implantation
Changes in left ventricular longitudinal strain measured by echocardiography
Time frame: 9 months after implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Derived from this study: PubMed 37038875Layec J, Decroocq M, Delelis F, Appert L, Guyomar Y, Riolet C, Dumortier H, Mailliet A, Tribouilloy C, Marechaux S, Menet A. Dyssynchrony and Response to Cardiac Resynchronization Therapy in Heart Failure Patients With Unfavorable Electrical Characteristics. JACC Cardiovasc Imaging. 2023 Jul;16(7):873-884. doi: 10.1016/j.jcmg.2022.12.023. Epub 2023 Mar 8.
- Derived from this study: PubMed 30595180Appert L, Menet A, Altes A, Ennezat PV, Bardet-Bouchery H, Binda C, Guyomar Y, Delelis F, Castel AL, Le Goffic C, Guerbaai RA, Graux P, Tribouilloy C, Marechaux S. Clinical Significance of Electromechanical Dyssynchrony and QRS Narrowing in Patients With Heart Failure Receiving Cardiac Resynchronization Therapy. Can J Cardiol. 2019 Jan;35(1):27-34. doi: 10.1016/j.cjca.2018.10.019. Epub 2018 Nov 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvestre Maréchaux, MD, PhD principal investigator
Hospital of Lille Catholic University (GHICL)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Cardiac Resynchronization Therapy, run by Lille Catholic University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amélie Lansiaux, MD, PhD (00 33 3 20 52 69, lansiaux.amelie@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in left ventricular end-systolic volume measured by echocardiography (time frame: 9 months after implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02986633, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.